MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	3000TFX
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Multiple requests for additional details regarding this event (i.E., medical records) have been performed; however, no additional information has been provided.The subject device is also unavailable for evaluation as the it remains implanted in the patient.Therefore, the reported event could not be confirmed.There is currently insufficient information to determine the root cause of this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any additional information is received, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that a patient with a 29mm 3000tfx pericardial valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of nine (9) years, nine (9) months due to regurgitation.The tavr was performed with a 29mm 9600tfx transcatheter valve.No additional information has been provided.
Additional Manufacturer Narrative
The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.The root cause of this event cannot be conclusively determined with the available information.However, the regurgitation in this case was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.Updated h6 type of investigation by adding code-3331.H11: corrected data: corrected h6 component codes by replacing code-439 with code-4755.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12192921
• Report Number: 2015691-2021-04193
• Device Sequence Number: 16517570
• Product Code: DYE
• UDI-Device Identifier: 00690103163681
• UDI-Public: 00690103163681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 3000TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR